Aquablation in Patients on Antithrombotics: Assessment of Safety, Postoperative Bleeding Rates and Clinical Outcomes.

OBJECTIVE: To analyze the impact of perioperative antithrombotic use on the bleeding outcomes following Aquablation. METHODS: One hundred sixteen men with who underwent Aquablation as part of the WATER prospective trial (NCT02505919) were assigned to 2 groups based on perioperative antithrombotic status. Antithrombotic cessation and restart timing were based on the surgeon's discretion. Methods of achieving intraoperative hemostasis consisted of no-cautery balloon tamponade or cautery. Primary endpoints included immediate postoperative hematuria rates and changes in hemoglobin. Secondary endpoints included 90-day bleeding complications and nonbleeding postoperative adverse events. RESULTS: Forty-one men took antithrombotic medications in the perioperative period while 75 men had no antithrombotic medication. Preoperative hemoglobin levels were comparable between both groups. Postoperative hemoglobin change from baseline (drop of 1.8 ± 1.5 g/dL among the antithrombotic group vs 1.8 ± 1.7 g/dL among the antithrombotic-naïve group) did not differ between both groups (P = .896). In total, 4 (9.8%) men in the antithrombotic group and 4 (5.3%) patients in the antithrombotic-naïve group experienced a Clavien-Dindo grade 1 complication (P = .451) in the 3-month postoperative period. Eight (19.5%) patients in the antithrombotic group and 11 (14.7%) patients in the antithrombotic-naïve group experienced a Clavien-Dindo grade 2 complication (P = .601), none of which is associated with bleeding in both groups. No men in either group demonstrated de novo erectile dysfunction. One patient (2.4%) in the antithrombotic group and none in the antithrombotic-naïve group required blood products (P = .353). CONCLUSION: Aquablation demonstrates comparable postoperative bleeding outcomes and other adverse effects for men with benign prostatic hypertrophy who are on antithrombotic therapy.

Aquablation Therapy in Large Prostates (80-150 mL) for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia: Final WATER II 5-Year Clinical Trial Results.

PURPOSE: We report 5-year safety and efficacy outcomes of the Aquablation procedure for the treatment of men with symptomatic benign prostatic hyperplasia and large-volume prostate glands. MATERIALS AND METHODS: A total of 101 men with moderate to severe benign prostatic hyperplasia symptoms and prostate volumes between 80 and 150 mL underwent a robotic-assisted Aquablation procedure in a prospective multicenter international trial (NCT03123250). Herein we report the final 5-year results. RESULTS: The study successfully met its safety and efficacy performance goal, which was based upon transurethral resection of the prostate outcomes typically done in smaller prostates, at 3 months. Mean prostate volume was 107 mL (range 80-150) at baseline. Patient symptoms showed a significant improvement where the mean (SD) International Prostate Symptom Score of 22.6 (6.4) at baseline to 6.8 (4.6) at 5 years, resulting in a change score of 15.9 (7.7, P < .001). Uroflowmetry measurements also demonstrated improvement where the mean maximum urinary flow rate increased from 8.6 (SD 3.4) to 17.1 (9.8) mL/s at 5 years, resulting in a change score of 9.2 (11.1) mL/s at 5 years (P < .001). A regression analysis evaluating change in PSA as a function of baseline PSA across all time points out to 5 years resulted in a 50% reduction. A prespecified subgroup analysis using a baseline prostate volume cutoff of 100 mL showed no difference in efficacy outcomes through 5 years. Freedom from a secondary benign prostatic hyperplasia procedure at 5 years was 96.3% based on Kaplan-Meier. CONCLUSIONS: At 5-years of prospective follow-up, the Aquablation procedure was shown to be safe with durable efficacy and low rates of retreatment in men with large prostates (80-150 mL).

Aquablation therapy in large prostates (80-150 cc) for lower urinary tract symptoms due to benign prostatic hyperplasia: WATER II 3-year trial results.

Objective: The objective of this study is to determine if Aquablation therapy can maintain its effectiveness in treating men with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) with large-volume (80-150 cc) prostates at 3 years. Subjects and Methods: One hundred one men with moderate-to-severe BPH symptoms and prostate volumes between 80 and 150 cc were enrolled in a prospective, nonrandomized, multicenter, international clinical trial in late 2017. Baseline, procedural, and follow-up parameters were recorded at baseline and scheduled postoperative visits. IPSS, Qmax, and treatment failure are reported at 3 years. Results: The mean prostate volume was 107 cc (range 80-150). Mean IPSS improved from 23.2 at baseline to 6.5 at 3 years (16.3-point improvement, p < 0.0001). Mean IPSS quality of life improved from 4.6 at baseline to 1.1 at 3 years (improvement of 3.4 points, p < 0.0001). Maximum urinary flow increased from 8.7 to 18.5 cc/s. At 3 year follow-up, 6% of treated patients needed BPH medication and an additional 3% required surgical retreatment for LUTS. Conclusions: Three-year follow-up demonstrates a sustained symptom reduction response along with low irreversible complications to Aquablation in men with LUTS due to BPH and prostates of 80-150 cc. Current treatment options available for men with prostates of this size have similar efficacy outcomes but are burdened with high rates of irreversible complications. There are now numerous clinical studies with Aquablation used in various prostates sizes, and it should be offered as an option to men with LUTS due to BPH.

Five-year outcomes for Aquablation therapy compared to TURP: results from a double-blind, randomized trial in men with LUTS due to BPH.

INTRODUCTION: To determine if Aquablation therapy can maintain long term effectiveness in treating men with moderate to severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) with a baseline prostate volume between 30 and 80 mL at 5 years compared to TURP. MATERIALS AND METHODS: In a double-blinded, multicenter prospective randomized controlled trial, 181 patients with moderate to severe LUTS secondary to BPH underwent TURP or Aquablation. The primary efficacy endpoint was reduction in International Prostate Symptom Score (IPSS) at 6 months. The primary safety endpoint was the occurrence of Clavien-Dindo persistent Grade 1 or Grade 2 or higher operative complications at 3 months. The assessments included IPSS, Male Sexual Health Questionnaire (MSHQ), International Index of Erectile Function (IIEF) and uroflow (Qmax). The patients were followed for 5 years. RESULTS: The primary safety endpoint was successfully achieved at 3 months where the Aquablation group had a lower event rate than TURP (26% vs. 42%, p = .0149 for superiority). Procedure-related ejaculatory dysfunction was lower for Aquablation (7% vs. 25%, p = .0004). The primary efficacy endpoint was successfully achieved at 6 months, where the mean IPSS decreased from baseline by 16.9 points for Aquablation and 15.1 points for TURP; the mean difference in change score at 6 months was 1.8 points larger for Aquablation (p < .0001 for non-inferiority, p = .1346 for superiority). At 5 years, IPSS scores improved by 15.1 points in the Aquablation group and 13.2 points in TURP (p = .2764). However, for men with larger prostates (≥ 50 mL), IPSS reduction was 3.5 points greater across all follow up visits in the Aquablation group compared to the TURP group (p = .0123). Improvement in peak urinary flow rate was 125% and 89% compared to baseline for Aquablation and TURP, respectively. The risk of patients needing a secondary BPH therapy, defined as needing BPH medication or surgical intervention, up to 5 years due to recurrent LUTS was 51% less in the Aquablation arm compared to the TURP arm. CONCLUSIONS: The improvement in net health outcomes from Aquablation therapy outweigh those offered by a TURP when considering the efficacy benefit along with the lower risk of needing a secondary BPH therapy and avoiding retrograde ejaculation. Following Aquablation therapy, symptom reduction and uroflow improvement at 5 years have shown to be durable and consistent across all years of follow up compared to TURP. Larger prostates (≥ 50 mL) demonstrated a larger safety and efficacy benefit for Aquablation over TURP.

Outcomes of Alternative Reservoir Placement in the Lateral Retroperitoneum During Inflatable Penile Prosthesis Placement.

OBJECTIVES: To describe outcomes of reservoir placement, exchange, and extraction from the lateral retroperitoneum (LR) in complex patients with a three-piece inflatable penile prosthesis (IPP). METHODS: A retrospective chart review was performed on all patients that underwent placement of an IPP from 2009 to 2019. Patients with placement of the reservoir in the LR were identified. Intraoperative complications during reservoir placement, exchange, or removal, reservoir-related outcomes, and secondary device-related outcomes were collated and compared to patients who underwent traditional Space of Retzius reservoir placement. RESULTS: A total of 587 men underwent primary IPP placement with 321 patients undergoing reservoir placement in the SOR and 266 in the LR. No significant differences were found in intra-operative reservoir-related outcomes (P=.272) between the 2 groups during placement, replacement, or extraction. Bowel injury occurred in 1 patient in the LR group during placement. No significant differences were found in postoperative reservoir complications (P= .534). Both groups each had one instance of patient reported bulge and pain at reservoir site (P= .6777). Two (0.6%) patients in the SOR group and 3 (1.1%) patients in the LR group had a reservoir failure or leak. There was a trend towards a lower rate of device infections in the LR group (1.9%) compared to the SOR group (4.7%) (P= .063). There were no significant differences in overall device mechanical failure rates between both groups (P= .919). CONCLUSIONS: Reservoir placement in the LR is safe in patients with complex pelvic anatomy with equivalent device durability and no difference in surgical outcomes compared to standard retropubic reservoir placement.

Aquablation for benign prostatic hyperplasia in large prostates (80-150 cc): 2-year results.

INTRODUCTION: To report 2-year safety and effectiveness of the Aquablation procedure for the treatment of men with symptomatic benign prostatic hyperplasia (BPH) and large-volume 80-150 cc prostates. MATERIALS AND METHODS: Between September-December 2017, 101 men with moderate-to-severe BPH symptoms and prostate volumes of 80-150 cc underwent an ultrasound-guided robotically executed Aquablation procedure in a prospective multicenter international clinical trial (WATER II). Baseline, procedural and follow up parameters were recorded at baseline and scheduled postoperative visits. Herein we report 2-year safety and efficacy for this cohort. RESULTS: Mean prostate volume was 107 cc (range 80-150 cc). Mean IPSS improved from 23.2 at baseline to 5.8 at 2 years (17-point improvement, p < .0001). Mean IPSS quality of life improved from 4.6 at baseline to 1.1 at 2 years (p < .0001). Maximum urinary flow increased from 8.7 to 18.2 cc/sec. Two subjects underwent a repeat procedure for BPH symptoms over the 2-year follow up period. By 2 years or study exit, all but 2 of 74 subjects stopped taking alpha blockers. Similarly, all but 4 of 32 subjects stopped taking 5α-reductase inhibitors. CONCLUSIONS: Two-year prospective multicenter follow up demonstrated that the Aquablation procedure is safe and effective in the treatment of men with LUTS due to BPH and prostates 80-150 cc with durable treatment efficacy, acceptable safety profile and a low retreatment rate. ClinicalTrials.gov number, NCT03123250.

Three-year outcomes after Aquablation therapy compared to TURP: results from a blinded randomized trial.

INTRODUCTION: To compare 3-year efficacy and safety after prostate resection with Aquablation therapy or transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms related to benign prostate hyperplasia (BPH). MATERIALS AND METHODS: One hundred and eighty-one patients assigned to either Aquablation therapy or TURP were followed for 3 years postoperatively. Patients and follow up assessors were blinded to treatment. Assessments included International Prostate Symptom Score (IPSS), Male Sexual Health Questionnaire (MSHQ-EjD), International Index of Erectile Function (IIEF) and uroflow. RESULTS: Over 3 years of treatment, improvements in IPSS scores were statistically similar across groups. Mean 3-year improvements were 14.4 and 13.9 points in the Aquablation and TURP groups, respectively (difference of 0.6 points, 95% CI -3.3-2.2, p = .6848). Similarly, 3-year improvements in Qmax were 11.6 and 8.2 cc/sec (difference of 3.3 [95% CI -0.5-7.1] cc/sec, p = .0848). At 3 years, PSA was reduced significantly in both groups by 0.9 and 1.1 ng/mL, respectively; the reduction was similar across groups (p = .5983). There were no surgical retreatments for BPH beyond 20 months for either Aquablation or TURP. CONCLUSIONS: Three-year BPH symptom reduction and urinary flow rate improvement were similar after TURP and Aquablation therapy. No subjects required surgical retreatment beyond 20 months postoperatively. (ClinicalTrials.gov number, NCT02505919).

Predictors of Device-related Complications After Exchange of the Pressure-regulating Balloon in Men With an Artificial Urinary Sphincter.

OBJECTIVE: To identify patient and component specific factors that predispose patients to device-related complications when undergoing pressure-regulating balloon (PRB) exchange in men with an artificial urinary sphincter (AUS). METHOD: From 2009 to 2018, 55 patients underwent AUS revision with placement of a higher pressure 71-80 cm H2O PRB to treat recurrent stress incontinence. Patient demographics, perioperative data, and postoperative outcomes were examined and multivariable logistic regression analyses performed to identify predictors of erosion and mechanical failure. RESULT: After a median follow-up of 26.4 months (range: 6-103.7 months), 21 of 55 (38.1%) patients developed a device-related complication that required operative repair or removal of the AUS. Four (7.3%) patients developed erosion after the PRB pressure increase and 5 patients showed evidence of impending erosion on follow-up and underwent successful revision surgery. Twelve patients developed mechanical failure (cuff leak, n = 7; pump malfunction, n =4; unidentified fluid loss, n = 1). Multivariable logistic regression analysis found that increasing body mass index was a predictor of mechanical failure. Hypertension and lower body mass index were found to increase the risk of cuff erosion whereas radiotherapy was not. CONCLUSION: In the carefully selected patient, PRB exchange can be performed to treat recurrent incontinence in patients with an AUS, including those treated with pelvic radiotherapy. Our data suggest that this technique is susceptible to a high rate of revision surgery. As such, when revising a functional AUS system, meticulous preoperative screening, comprehensive informed consent, and follow-up protocols are essential in minimizing adverse events.

Aquablation for Benign Prostatic Hyperplasia in Large Prostates (80-150 cc): 1-Year Results.

OBJECTIVE: To report 12-month safety and effectiveness outcomes of the Aquablation procedure for the treatment of men with symptomatic benign prostatic hyperplasia (BPH) and large-volume prostates. METHODS: One hundred and one men with moderate-to-severe BPH symptoms and prostate volumes of 80-150 cc underwent a robotic-assisted Aquablation procedure in a prospective multicenter international clinical trial. Functional and safety outcomes were assessed at 12 months postoperatively. RESULTS: Mean prostate volume was 107 cc (range 80-150). Mean operative time was 37 minutes and mean Aquablation resection time was 8 minutes. The average length of hospital stay following the procedure was 1.6 days. Mean International Prostate Symptom Score improved from 23.2 at baseline to 6.2 at 12 months (P <.0001). Mean International Prostate Symptom Score quality of life improved from 4.6 at baseline to 1.3 at 12-month follow-up (P <.0001). Significant improvements were seen in Qmax (12-month improvement of 12.5 cc/sec) and postvoid residual (drop of 171 cc in those with postvoid residual >100 at baseline). Antegrade ejaculation was maintained in 81% of sexually active men. No patient underwent a repeat procedure for BPH symptoms. There was a 2% de novo incontinence rate at 12 months, and 10 patients did require a transfusion postoperatively while 5 required take back fulgurations. At 12 months, prostate-specific antigen reduced from 7.1 ± 5.9 ng/mL at baseline to 4.4 ± 4.3 ng/mL. CONCLUSION: The Aquablation procedure is demonstrated to be safe and effective in treating men with large prostates (80-150 cc) after 1 year of follow-up, with an acceptable complication rate and without a significant increase in procedure or resection time compared to smaller sized glands. ClinicalTrials.gov number, NCT03123250.

Delayed Presentation of Urethro-Cavernosal Fistula After Urotrauma.

OBJECTIVE: To define clinical features and surgical management of urethro-cavernosal fistulas (UCF). METHODS: A literature search was performed using PubMed to identify publications with the key word urethro-cavernosal fistula. RESULTS: We herein describe surgical techniques and long-term outcomes for UCF repair. CONCLUSION: UCFs is a rare urological condition with only 9 cases reported to date. UCFs can be diagnosed with careful history, physical examination, and retrograde urethrography. Surgical management includes basic tenets of fistula repair, including adequate mobilization, tension-free but watertight approximation, multilayered closure with nonoverlapping suture lines, and maximal bladder drainage.

Two-Year Outcomes After Aquablation Compared to TURP: Efficacy and Ejaculatory Improvements Sustained.

INTRODUCTION: To compare 2-year safety and efficacy outcomes after Aquablation or transurethral resection of the prostate (TURP) for the treatment of lower urinary tract symptoms related to benign prostate hyperplasia (BPH). METHODS: One hundred eighty-one patients with BPH were assigned at random (2:1 ratio) to either Aquablation or TURP. Patients and follow-up assessors were blinded to treatment. Assessments included the International Prostate Symptom Score (IPSS), Male Sexual Health Questionnaire (MSHQ), International Index of Erectile Function and uroflow. The focus of analysis was 2-year outcomes. RESULTS: At 2 years, IPSS scores improved by 14.7 points in the Aquablation group and 14.9 points in TURP (p = .8304, 95% CI for difference - 2.1 to 2.6 points). Two-year improvements in maximum flow rate (Qmax) were large in both groups at 11.2 and 8.6 cc/s for Aquablation and TURP, respectively (p = 0.1880, 95% CI for difference - 1.3 to 6.4). Sexual function as assessed by MSHQ was stable in the Aquablation group and decreased slightly in the TURP group. At 2 years, PSA was reduced significantly in both groups by 0.7 and 1.2 points, respectively; the reduction was similar across groups (p = 0.1816). Surgical retreatment rates after 12 months for Aquablation were 1.7% and 0% for TURP. Over 2 years, surgical BPH retreatment rates were 4.3% and 1.5% (p = 0.4219), respectively. CONCLUSION: Two-year efficacy outcomes after TURP and Aquablation were similar, and the rate of surgical retreatment was low and similar to TURP. TRIAL REGISTRATION: ClinicalTrials.gov no. NCT02505919. FUNDING: PROCEPT BioRobotics.

Aquablation for benign prostatic hyperplasia in large prostates (80-150 mL): 6-month results from the WATER II trial.

OBJECTIVE: To present 6-month safety and effectiveness data from a multicentre prospective study of aquablation in men with lower urinary tract symptoms (LUTS) attributable to benign prostatic hyperplasia (BPH) with prostate volumes between 80 and 150 mL. METHODS: Between September and December 2017, 101 men with LUTSattributable to BPHwere prospectively enrolled at 16 centres in Canada and the USA. RESULTS: The mean prostate volume was 107 mL. The mean length of hospital stay after the aquablation procedure was 1.6 days (range: same day to 6 days). The primary safety endpoint (Clavien-Dindo grade 2 or higher or any grade 1 event resulting in persistent disability) at 3 months occurred in 45.5% of men, which met the study design goal of < 65% (P < 0.001). At 6 months, 22% of the patients had experienced a Clavien-Dindo grade 2, 14% a grade 3 and 5% a grade 4 adverse event. Bleeding complications requiring intervention and/or transfusion were recorded in eight patients prior to discharge and in six patients after discharge. The mean International Prostate Symptom Score improved from 23.2 ± 6.3 at baseline to 6.7 ± 5.1 at 3 months, meeting the study's primary efficacy endpoint goal (P < 0.001). The maximum urinary flow rate increased from 8.7 to 18.8 mL/s (P < 0.001) and post-void residual urine volume decreased from 131 at baseline to 47 at 6 months (P < 0.0001). At 6 months, prostate-specific antigen concentration reduced from 7.1 ± 5.9 ng/mL at baseline to 4.0 ± 3.9 ng/mL, a 44% reduction. CONCLUSIONS: Aquablation is safe and effective in treating men with larger prostates (80-150 mL), without significant increase in procedure or resection time.

Symptom relief and anejaculation after aquablation or transurethral resection of the prostate: subgroup analysis from a blinded randomized trial.

OBJECTIVE: To test the hypothesis that benign prostatic hyperplasia (BPH) robotic surgery with aquablation would have a more pronounced benefit in certain patient subgroups, such as men with more challenging anatomies (e.g. large prostates, large middle lobes) and men with moderate BPH. METHODS: We conducted prespecified and post hoc exploratory subgroup analyses from a double-blind, multicentre prospective randomized controlled trial that compared transurethral resection of the prostate (TURP) using either standard electrocautery vs surgery using robotic waterjet (aquablation) to determine whether certain baseline factors predicted more marked responses after aquablation as compared with TURP. The primary efficacy endpoint was reduction in International Prostate Symptom Score (IPSS) at 6 months. The primary safety endpoint was the occurrence of Clavien-Dindo persistent grade 1 or grade ≥2 surgical complications. RESULTS: For men with larger prostates (50-80 g), the mean IPSS reduction was four points greater after aquablation than after TURP (P = 0.001), a larger difference than the overall result (1.8 points; P = 0.135). Similarly, the primary safety endpoint difference (20% vs 46% [26% difference]; P = 0.008) was greater for men with large prostate compared with the overall result (26% vs 42% [16% difference]; P = 0.015). Postoperative anejaculation was also less common after aquablation compared with TURP in sexually active men with large prostates (2% vs 41%; P < 0.001) vs the overall results (10% vs 36%; P < 0.001). Exploratory analysis showed larger IPSS changes after aquablation in men with enlarged middle lobes, men with severe middle lobe obstruction, men with a low baseline maximum urinary flow rate, and men with elevated (>100) post-void residual urine volume. CONCLUSIONS: In men with moderate-to-severe lower urinary tract symptoms attributable to BPH and larger, more complex prostates, aquablation was associated with both superior symptom score improvements and a superior safety profile, with a significantly lower rate of postoperative anejaculation. The standardized, robotically executed, surgical approach with aquablation may overcome the increased outcome variability in more complex anatomy, resulting in superior symptom score reduction.

WATER II (80-150 mL) procedural outcomes.

OBJECTIVES: To present early safety and feasibility data from a multicentre prospective study (WATER II) of aquablation in the treatment of symptomatic men with large-volume benign prostatic hyperplasia (BPH). METHODS: Between September and December 2017, 101 men with moderate-to-severe BPH symptoms and prostate volume of 80-150 mL underwent aquablation in a prospective multicentre international clinical trial. Baseline demographics and standardized postoperative management variables were carefully recorded in a central independently monitored database. Surgeons answered analogue scale questionnaires on intra-operative technical factors and postoperative management. Adverse events up to 1 month were adjudicated by an independent clinical events committee. RESULTS: The mean (range) prostate volume was 107 (80-150) mL. The mean (range) operating time was 37 (15-97) min and aquablation resection time was 8 (3-15) min. Adequate adenoma resection was achieved with a single pass in 34 patients and with additional passes in 67 patients (mean 1.8 treatment passes), all in a single operating session. Haemostasis was achieved using either a Foley balloon catheter placed in the bladder under traction (n = 98, mean duration 18 h) or direct tamponade using a balloon inflated in the prostate fossa (n = 3, mean duration 15 h). No patient required electrocautery for haemostasis at the time of the primary procedure. The mean length of stay after the procedure was 1.6 days (range same day to 6 days). The Clavien-Dindo grade ≥2 event rate observed at 1 month was 29.7%. Bleeding complications were recorded in 10 patients (9.9%) during the index procedure hospitalization prior to discharge, and included six (5.9%) peri-operative transfusions. CONCLUSIONS: Aquablation is feasible and safe in treating men with men with large prostates (80-150 mL). The 6-month efficacy data are being accrued and will be presented in future publications (ClinicalTrials.gov number, NCT03123250).

Mechanical failure rates of artificial urinary sphincter components: Is the 3.5-cm urethral cuff at higher risk?

AIM: We report the rates of artificial urinary sphincter (AUS) mechanical failure in a contemporary cohort of patients stratified by component type and size to determine if the 3.5-cm cuff is at higher risk of failure. METHODS: From 2005-2016, a total of 486 male patients with stress incontinence underwent implantation or revision of an AUS. 993 individual cases were retrospectively reviewed (465 primary placements and 528 revisions). Components were separately tallied and cases of mechanical failure were identified. Multiple variables including duration until failure and follow-up interval were collected and analyzed for each malfunction. RESULTS: After median follow-up of 31.5 months, there were 48 distinct cases of mechanical failure. The urethral cuff was the most common component to fail (n = 27, 56.3%), followed by the pressure regulating balloon (PRB) (n = 6, 12.5%), tubing (n = 6, 12.5%), and the control pump, (n = 5, 10.4%). Four (8.3%) cases did not have the source of malfunction identifiable in available records though fluid loss was evident at the time of device interrogation. Sub-analyses of cuff failure events showed that the 3.5-cm cuff had a statistically significant higher risk of failure (HR: 7.313, (P < .0001) compared to larger cuff sizes. CONCLUSIONS: While each component is prone to malfunction, our study suggests that the 3.5-cm urethral cuff is more susceptible to failure and failure events occur earlier after placement than larger cuff sizes.

Robotic Management of Rectourethral Fistulas After Focal Treatment for Prostate Cancer.

OBJECTIVE: To describe our management strategy for rectourethral fistula (RUF) after focal treatment for prostate cancer (PCa) using 2 cases as an example. Almost 50% of RUFs are associated with energy treatment modalities for PCa. The adjacent damage to healthy tissue along with limited pliability of it makes the success of the repair troublesome. There is no standardized approach for these scenarios. MATERIALS AND METHODS: For case 1, an 83-year-old man underwent cryotherapy for PCa. On postoperative day 14, he presented with urine per rectum. Cystoscopy confirmed the presence of an RUF. Urinary and fecal diversions were unsuccessful. Three months later, robotic surgical repair was performed. For case 2, an 85-year-old man underwent salvage therapy for PCa with high-intensity focused ultrasound after previous treatment with external beam radiation therapy. Two months postoperatively, he presented with urine per rectum. A computed tomography scan confirmed the presence of an RUF. Robotic surgical repair was subsequently performed. RESULTS: Both patients underwent robotic-assisted RUF repair, including salvage prostatectomy , rectal defect closure, and omental flap placement. In the first case, healthy urethra was present after the salvage prostatectomy, and the next step was completion of a vesicourethral anastomosis. In the second case, the next step was closure of the bladder neck and suprapubic tube placement due to the extensive tissue destruction the residual urethra. Success was confirmed with imaging studies and no reported symptoms at 9 and 4 months, respectively. CONCLUSION: The robotic system is useful for the treatment of a complicated RUF. The optimal reconstruction strategy depends on the ability to reach the distal urethra, the patients' characteristics, and preferences.

Three-Piece Inflatable Penile Prosthesis Placement Following Pelvic Radiation: Technical Considerations and Contemporary Outcomes.

BACKGROUND: Pelvic radiation is a known risk factor for the development and progression of erectile dysfunction. When medical therapy fails, the 3-piece inflatable penile prosthesis (IPP) can offer patients a definitive treatment option. Because of radiation-induced vascular changes and tissue fibrosis, a careful surgical approach is necessary to avoid intraoperative complications and attain successful outcomes. Despite its widespread use in prostate cancer treatment, there are no contemporary studies examining the effects that pelvic radiation can have on 3-piece IPP placement and device survival. AIM: To present technical considerations and contemporary outcomes of placing a 3-piece IPP for refractory erectile dysfunction in patients with a history of pelvic radiation. METHODS: We retrospectively reviewed 78 patients who underwent placement of a 3-piece IPP (AMS 700; Boston Scientific, Marlborough, MA, USA) after being treated with pelvic radiotherapy from 2003 through 2016. All patients had been treated with external beam and/or brachytherapy for treatment of prostate malignancy. An infrapubic approach was used in all patients, with reservoir placement in the space of Retzius or in the lateral retroperitoneal space. Patient demographics, perioperative data, and postoperative outcomes including prosthetic infection and mechanical failure were examined and statistical analysis was performed. OUTCOMES: Rates of device infection, revision surgery, and reservoir complications. RESULTS: No intraoperative complications were observed. After a mean follow-up of 49.0 months (6.6-116.8), 2 patients developed an infection of their prosthesis that required explantation. These patients underwent successful IPP removal and immediate reimplantation. 11 patients (14.1%) required revision surgery (pump replacement, n = 4; pump relocation, n = 2; cylinder replacement, n = 4; reservoir replacement owing to leak, n = 1). No reservoir-related complications such as herniation or erosion into adjacent structures were observed. CLINICAL IMPLICATIONS: The 3-piece IPP can be placed safely in a broad range of patients treated with pelvic radiotherapy. STRENGTHS AND LIMITATIONS: This study describes contemporary long-term outcomes of the IPP in patients treated with pelvic radiation and includes patients with prior pelvic surgery and artificial urinary sphincter, which are commonly encountered in practice. It is limited by its single-center experience and lacks a comparison group of patients. Objective patient satisfaction data were not available for inclusion. CONCLUSIONS: The 3-piece IPP can be placed successfully in patients with a history of pelvic radiation without a significant increase in infectious complications, reservoir erosion, or mechanical failure compared with the global literature. Loh-Doyle J, Patil MB, Nakhoda Z, et al. Three-Piece Inflatable Penile Prosthesis Placement Following Pelvic Radiation: Technical Considerations and Contemporary Outcomes. J Sex Med 2018;15:1049-1054.

WATER: A Double-Blind, Randomized, Controlled Trial of Aquablation® vs Transurethral Resection of the Prostate in Benign Prostatic Hyperplasia.

PURPOSE: We compared the safety and efficacy of Aquablation and transurethral prostate resection for the treatment of lower urinary tract symptoms related to benign prostatic hyperplasia. MATERIALS AND METHODS: In a double-blind, multicenter, prospective, randomized, controlled trial 181 patients with moderate to severe lower urinary tract symptoms related to benign prostatic hyperplasia underwent transurethral prostate resection or Aquablation. The primary efficacy end point was the reduction in International Prostate Symptom Score at 6 months. The primary safety end point was the development of Clavien-Dindo persistent grade 1, or 2 or higher operative complications. RESULTS: Mean total operative time was similar for Aquablation and transurethral prostate resection (33 vs 36 minutes, p = 0.2752) but resection time was lower for Aquablation (4 vs 27 minutes, p <0.0001). At month 6 patients treated with Aquablation and transurethral prostate resection experienced large I-PSS improvements. The prespecified study noninferiority hypothesis was satisfied (p <0.0001). Of the patients who underwent Aquablation and transurethral prostate resection 26% and 42%, respectively, experienced a primary safety end point, which met the study primary noninferiority safety hypothesis and subsequently demonstrated superiority (p = 0.0149). Among sexually active men the rate of anejaculation was lower in those treated with Aquablation (10% vs 36%, p = 0.0003). CONCLUSIONS: Surgical prostate resection using Aquablation showed noninferior symptom relief compared to transurethral prostate resection but with a lower risk of sexual dysfunction. Larger prostates (50 to 80 ml) demonstrated a more pronounced superior safety and efficacy benefit. Longer term followup would help assess the clinical value of Aquablation.

Surviving Fournier's gangrene: Multivariable analysis and a novel scoring system to predict length of stay.

BACKGROUND: There is no contemporary scoring system to predict hospital length of stay and morbidity in Fournier's gangrene. A retrospective study was conducted to formulate a scoring system to predict duration of hospitalization, resource utilization, need for reconstruction, morbidity and mortality. METHODS: A retrospective chart review was performed on 54 patients treated for FG from 2010-2016 at LAC+USC Medical Center, the largest public hospital in Los Angeles County. Strobe guidelines were followed and the study was approved by the IRB. Predictors of LOS, morbidity, mortality and resource utilization were identified and univariate linear regressions performed to determine significance. Significant univariate predictors were used to develop a novel scoring system, the Combined Urology and Plastics Index (CUPI). The CUPI score was then compared to existing scoring systems for predicting length of stay. RESULTS: The mean patient age was 49.3, and the mean BMI was 28.6. Patients on average were hospitalized for 37.5 days, with a mean of 8.3 days in the ICU. Three patients (5.6%) died during their hospital stay, and 33 (61%) required reconstructive surgery. Multivariate logistic modeling showed that BMI (p = 0.001) and alkaline phosphatase (p < 0.001) correlated with decreasing length of stay, while age at admission was not significantly correlated (p = 0.369). Univariate analysis of existing scoring systems showed that FGSI, LRINEC, NLR, and CCI were not significantly correlated with length of stay, while the newly calculated CUPI score was shown to be a significant predictor of longer hospital stays (p = 0.001). DISCUSSION: Early emphasis on supportive care, nutrition, and involvement of reconstructive surgeons can decrease LOS in patients with Fournier's gangrene. The CUPI score on admission may be a useful tool for predicting LOS in this population.